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Terrestrialbio

Engineer I/II, Process Development

Woburn, MAOnsite · United States
Mid-level · FullTime · Product Development
POSTED 25 SEPT
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Role
45 days opentrue age
Posted 25 Sept
Pay
$112k–$150kno pay posted
Market p25–p75
$112k–$150k
United States · n=429 · 365d to 6 Nov
CompanyTerrestrialbio →
11open roles
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Terrestrial Bio

Location: Allston, MA and Woburn, MA

About Terrestrial Bio, Inc.

Terrestrial is transforming the delivery of next-generation therapies, starting with GLP-1.

Terrestrial's proprietary Tacterra™ microarray patch (MAP) and applicator platform consists of a patch resembling an adhesive bandage, which is applied with a preloaded applicator and removed after a few minutes. Once applied, each patch delivers bioactive tips into the skin, which dissolve quickly into the body, rapidly releasing their therapeutic payload. Designed for self-administration, the temperature-stable Tacterra™ platform enables precise, controlled delivery of a wide range of therapeutics without medical sharps or refrigeration.

Terrestrial has generated strong clinical and in-vivo proof of concept across multiple molecules. For more information, visit www.terrestrialbio.com.

Why this role

Making microarray patches with hundreds or thousands of drug-loaded polymer microneedles — and ensuring consistent quality across a patch, a batch, or a manufacturing campaign — requires many processes to go just right, many, many times. This is where you get to dig in and make that happen. To that end, you will use your technical expertise to:

Get your hands on equipment and operations, building a first-principles understanding of how each unit operation affects product quality

Analyze process data to identify trends, troubleshoot deviations, and propose improvements

Grow your technical expertise by partnering with automation engineering, technical operations, and analytical/formulation development on real, moving problems, not hypotheticals

What you'll do

You will leverage your creativity, hands-on technical skills, and process engineering fundamentals to:

Characterize and improve manufacturing process unit operations by designing, executing, and analyzing process development experiments; communicate results via written reports and oral presentations to internal and project teams

Support manufacturing scale-up through hands-on assessment of novel equipment, workflows, analytical techniques/PAT, and process configurations

Support phase-appropriate cGMP manufacturing operations by drafting, revising, and reviewing process development histories, master batch records, process and equipment O&M SOPs, and other manufacturing documentation within Terrestrial’s Quality Management System

Develop and implement new or improved processes and controls to increase quality and throughput

Design tools, fixtures, and machines for manufacturing Terrestrial’s products

Collaborate closely with cross-functional teams to support product development and manufacturing activities

How you'll impact

Within your first 6–12 months, success likely looks like:

Fluency with Terrestrial’s microarray patch manufacturing process and the unit operations behind it

Ownership of at least one process development experiment or equipment assessment, from design through results

Contributions to cGMP documentation — SOPs, batch records, or process development histories — that hold up to quality review

Trusted, hands-on partnership with automation, technical operations, and quality colleagues

Who you are

B.S. in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related discipline with 0-2 years of experience (internship, co-op, or academic research experience) for Process Engineer I and 3+ years of relevant hands-on experience in medical devices or pharmaceutical development/manufacturing for Process Engineer II

Experience with automated manufacturing equipment or process development strongly preferred

Hands-on experience designing, executing, and analyzing process development experiments, with strong data analysis and communication skills

Familiarity or experience working in a cleanroom and/or a biomedical laboratory environment

Comfort standing or sitting for up to 8 hours, and performing tasks on laboratory benchtops and within glovebox isolators

Relevant direct experience in medical devices or pharmaceuticals — internship, co-op, or prior work experience all count

Source · TerrestrialbioFirst seen 7 NovOriginal ↗